Conditions
Hypertension, Pulmonary, Pulmonary Arterial Hypertension
Trial Purpose
This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH).
The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12.
The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12.
NATIONAL TRIAL REFERENCE NUMBER
NCT04732221
When you talk with your doctor or clinical trial team member, please have the national trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18 - 75
Sex
All
About the trial
Current trial phase
Trial Phase 2
In Phase 2 trials, researchers try to find out if a treatment works in about 100-500 participants – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials happen in hospitals, clinics, or doctor’s offices.
Trial Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000-5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials happen in hospitals, clinics, or doctor’s offices.
Trial start and end dates
- Trial start date May 19, 2021
- Estimated primary completion date December 2, 2024
- Estimated trial completion date October 29, 2026
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about